MAUDE Adverse Event Report: ZIMMER SURGICAL ELECTRIC DERMATOME HANDPIECE

Catalog Number 00-8821-001-00

Device Problem Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2014

Event Type  malfunction  

Event Description

It was reported that the zimmer electric dermatome runs intermittently.No additional clinical information was received prior to this report.If additional information is received, a follow up medwatch will be submitted.

Manufacturer Narrative

Beginning (b)(6) 2012, us and (b)(6) customers were sent an urgent patient safety advisory informing of the need for proper care and preventive maintenance of their zimmer electric dermatome.Customers were informed that improperly maintained instruments may cause donor site injuries or result in damage to the graft.Customers were requested to contact zimmer to schedule maintenance for the device in accordance with the instructions for use.The device was returned to the manufacturer for repair and evaluation.The service record indicates that the device was manufactured on 07/11/1995, and was last repaired on 02/16/2010 for a non-related issue.Evaluation of the device confirmed the device to operate intermittently, as operation ceased after the third power cycle.In addition, the width plate screws were missing and the reciprocating arm and thickness control lever were older style components.Prior to repair, the device was outside calibration specifications only at the zero thickness setting on the left side, and side to side calibration.In post-repair, corrosion of the exterior motor casing was observed.The motor operated within motor voltage specification and the power switch passed a continuity test.Customer did not return a power supply for evaluation.Lack of preventative maintenance most likely allowed the damage to the motor to occur over time and improper handling related to cleaning or sterilization of the unit most likely allowed moisture to enter the handpiece, corroding the motor over time.The device was serviced and returned to the customer.

• Brand Name: ELECTRIC DERMATOME HANDPIECE
• Type of Device: ELECTRIC DERMATOME HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio ave.; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 3753684
• MDR Text Key: 4484328
• Report Number: 1526350-2014-00070
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-8821-001-00
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2014
• Initial Date FDA Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/1995
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 61798
• Patient Sequence Number: 1